Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets

October 27, 2011 updated by: AstraZeneca

An Open-label, Partially Randomized, 5-way Crossover Study in Healthy Volunteers to Assess the Relative Bioavailability of 100 and 150 mg Fostamatinib Tablets Compared With 50 mg Fostamatinib Tablets

Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Provision of signed and dated informed consent prior to any study specific procedures
  • Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
  • Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
  • Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
Fostamatinib 50 mg tablet x 2 (Phase 3 batch)
Drug: Fostamatinib
Oral tablets, 50 mg x 2, single dose
Drug: Fostamatinib
Oral tablets, 50 mg x 3, single dose
Drug: Fostamatinib
Oral tablets, 100 mg, single dose
Drug: Fostamatinib
Oral tablets, 150 mg, single dose
Sham Comparator: B
Fostamatinib 50 mg tablet x 3 (Phase 3 batch)
Drug: Fostamatinib
Oral tablets, 50 mg x 2, single dose
Drug: Fostamatinib
Oral tablets, 50 mg x 3, single dose
Drug: Fostamatinib
Oral tablets, 100 mg, single dose
Drug: Fostamatinib
Oral tablets, 150 mg, single dose
Experimental: C
Fostamatinib 100 mg tablet (new formulation)
Drug: Fostamatinib
Oral tablets, 50 mg x 2, single dose
Drug: Fostamatinib
Oral tablets, 50 mg x 3, single dose
Drug: Fostamatinib
Oral tablets, 100 mg, single dose
Drug: Fostamatinib
Oral tablets, 150 mg, single dose
Experimental: D
Fostamatinib 150 mg tablet (new formulation)
Drug: Fostamatinib
Oral tablets, 50 mg x 2, single dose
Drug: Fostamatinib
Oral tablets, 50 mg x 3, single dose
Drug: Fostamatinib
Oral tablets, 100 mg, single dose
Drug: Fostamatinib
Oral tablets, 150 mg, single dose
Experimental: E
Fostamatinib 50 mg tablet x 2 (Phase 3 batch)
Drug: Fostamatinib
Oral tablets, 50 mg x 2, single dose
Drug: Fostamatinib
Oral tablets, 50 mg x 3, single dose
Drug: Fostamatinib
Oral tablets, 100 mg, single dose
Drug: Fostamatinib
Oral tablets, 150 mg, single dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation)
Time Frame: From Pre-dose until 96 hours post dose of each treatment period
Assessments will include but is not limited to: plasma R406 AUC, Cmax
From Pre-dose until 96 hours post dose of each treatment period
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation)
Time Frame: From pre-dose until 96 hours post dose of each treatment period
Assessments will include but is not limited to: plasma R406 AUC, Cmax )
From pre-dose until 96 hours post dose of each treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches
Time Frame: From pre-dose until 96 hours post dose of each treatment period
The safety endpoints will include adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
From pre-dose until 96 hours post dose of each treatment period
To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions.
Time Frame: From pre-dose until 96 hours post dose of each treatment period
Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax
From pre-dose until 96 hours post dose of each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D4300C00018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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